Australia - English - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - apomorphine hydrochloride hemihydrate, quantity: 10 mg/ml - injection, solution - excipient ingredients: sodium metabisulfite; sodium hydroxide; hydrochloric acid; water for injections - apomorphine wockhardt solution for injection or infusion is indicated to reduce the number and severity of ?off? phases in patients with parkinson?s disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. conventional therapy should be continued during ?on? phases.

United States - English - NLM (National Library of Medicine)

trupharma, llc - apomorphine hydrochloride (unii: f39049y068) (apomorphine - unii:n21far7b4s) - apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced parkinson's disease. apomorphine hydrocloride inejction has been studied as an adjunct to other medications [see clinical studies (14)] . apomorphine hydrocloride is contraindicated in patients: - using concomitant drugs of the 5ht3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see drug interactions (7.1)] . there have been reports of profound hypotension and loss of consciousness when apomorphine hydrocloride was administered with ondansetron. - with hypersensitivity/allergic reaction to apomorphine or to any of the excipients of apomorphine hydrocloride, including a sulfite (i.e., sodium metabisulfite). angioedema or anaphylaxis may occur [see warnings and precautions (5.12)]. risk summary there are no adequate data on the developmenta

Australia - English - Department of Health (Therapeutic Goods Administration)

interpharma pty ltd - apomorphine hydrochloride hemihydrate, quantity: 5 mg/ml - injection, solution - excipient ingredients: sodium metabisulfite; sodium chloride; hydrochloric acid; water for injections - indicated to reduce the number and severity of ?off? phases in patients with parkinson?s disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. conventional therapy should be continued during ?on? phases.

Australia - English - Department of Health (Therapeutic Goods Administration)

stada pharmaceuticals australia pty ltd - apomorphine hydrochloride hemihydrate, quantity: 50 mg - injection, solution - excipient ingredients: sodium metabisulfite; water for injections; hydrochloric acid - movapo pfs is indicated to reduce the number and severity of "off" phases in patients with parkinson's disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with apomorphine injection should be undertaken by a specialist unit in a hospital setting. conventional therapy should be continued during "on" phases.

Ireland - English - HPRA (Health Products Regulatory Authority)

pharmaceuticals sales & development sweden ab (pharmswed) - apomorphine hydrochloride hemihydrate - solution for infusion - 5 milligram(s)/millilitre - dopamine agonists; apomorphine

Ireland - English - HPRA (Health Products Regulatory Authority)

evolan pharma ab - apomorphine hydrochloride hemihydrate - solution for infusion - 5 milligram(s)/millilitre - dopamine agonists; apomorphine

United States - English - NLM (National Library of Medicine)

mdd us operations, llc - apomorphine hydrochloride (unii: f39049y068) (apomorphine - unii:n21far7b4s) - apomorphine hydrochloride 30 mg in 3 ml - apokyn (apomorphine hydrochloride injection) is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced parkinson's disease. apokyn has been studied as an adjunct to other medications [see clinical studies (14)] . apokyn is contraindicated in patients: - using concomitant drugs of the 5ht 3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see drug interactions (7.1)] . there have been reports of profound hypotension and loss of consciousness when apokyn was administered with ondansetron. - with hypersensitivity/allergic reaction to apomorphine or to any of the excipients of apokyn, including a sulfite (i.e., sodium metabisulfite). angioedema or anaphylaxis may occur [see warnings and precautions (5.13)]. risk summary there are no adequate data on the developmental risk associated with use of apokyn in pregnant women. in animal reproduction studies, apomorphine had adverse developmental effects in rats (increased neonatal deaths) and rabbits (increased incidence of malformation) when administered during pregnancy at clinically relevant doses. these doses were also associated with maternal toxicity [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data no adverse developmental effects were observed when apomorphine (0.3, 1, or 3 mg/kg/day) was administered by subcutaneous injection to pregnant rats throughout organogenesis; the highest dose tested is 1.5 times the maximum recommended human dose (mrhd) of 20 mg/day on a mg/m 2 basis. administration of apomorphine (0.3, 1, or 3 mg/kg/day) by subcutaneous injection to pregnant rabbits throughout organogenesis resulted in an increased incidence of malformations of the heart and/or great vessels at the mid and high doses; maternal toxicity was observed at the highest dose tested. the no-effect dose for adverse developmental effects is less than the mrhd on a mg/m 2 basis. apomorphine (0.3, 1, or 3 mg/kg/day), administered by subcutaneous injection to females throughout gestation and lactation, resulted in increased offspring mortality at the highest dose tested, which was associated with maternal toxicity. there were no effects on developmental parameters or reproductive performance in surviving offspring. the no-effect dose for developmental toxicity (1 mg/kg/day) is less than the mrhd on a mg/m 2 basis. risk summary there are no data on the presence of apomorphine in human milk, the effects of apomorphine on the breastfed infant, or the effects of apomorphine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for apokyn and any potential adverse effects on the breastfed infant from apokyn or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. in the apokyn clinical development program, there were 239 patients less than age 65 treated with apokyn and 311 patients who were age 65 or older. confusion and hallucinations were reported more frequently with patients age 65 and older compared to patients with less than age 65. serious adverse reactions (life-threatening events or events resulting in hospitalization and/or increased disability) were also more common in patients age 65 and older. patients age 65 and older were more likely to fall (experiencing bone and joint injuries), have cardiovascular events, develop respiratory disorders, and have gastrointestinal events. patients age 65 and above were also more likely to discontinue apokyn treatment as a result of one or more adverse reactions. the starting apokyn dose should be reduced in patients with mild or moderate renal impairment because the concentration and exposure (c max and auc) are increased in these patients. studies in subjects with severe renal impairment have not been conducted [see dosage and administration (2.4) and clinical pharmacology (12.3)] . caution should be exercised when administrating apokyn to patients with mild and moderate hepatic impairment because of the increased c max and auc in these patients. closely monitor patients with mild and moderate hepatic impairment. studies of subjects with severe hepatic impairment have not been conducted [see clinical pharmacology (12.3)] . in premarketing clinical experience, apokyn did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior. however, there are rare postmarketing reports of abuse of medications containing apokyn or levodopa. in general, these reports consist of patients taking increasing doses of medication in order to achieve a euphoric state. designed to be used only with 3 ml apokyn ® (apomorphine hydrochloride injection) cartridges for more information, call your specialty pharmacy provider or 1-877-7apokyn (727-6596). apokyn ® (apomorphine hydrochloride injection) apokyn pen - apokyn ® (apomorphine hydrochloride injection) is for under the skin (subcutaneous) injection only. - do not inject apokyn into a vein. - do not use the apokyn ® pen unless you and your care partner have been taught the right way to use it and both of you understand all of the instructions. - the apokyn pen is for use only with 3 ml apokyn ® (apomorphine hydrochloride injection) cartridges. - the apokyn pen is only for use by 1 patient and should not be shared. read first: important safety information - the apokyn pen is a medicine delivery device. it is very important that you or your care partner read this instructions for use and follow the instructions for using the apokyn pen correctly to receive the correct apokyn dose. - always perform a flow check (prime) before every injection and after loading a new cartridge. - the liquid in the apokyn cartridge can cause irritation if it gets on your skin or in your eyes. flush your eyes with cold water and wash the liquid off your skin right away if this happens. - the bd pen needle unit is sterile. avoid contaminating the needle after opening. do not place it on a surface or touch other items with the needle. - do not dial the dose or try to correct a dialing error with the pen needle in the skin. you could receive the wrong dose. - be careful when removing the needle. accidental needle sticks can transmit serious infections. never store or carry the apokyn pen with a pen needle attached. - air enter the cartridge - medicine leak out the apokyn pen should only be used with pen needles (29g × 1/2"). these needles are available through your specialty pharmacy provider or your local pharmacy. how to use the apokyn pen preparing (priming) the apokyn pen for use storage information –store apokyn cartridges at room temperature, 68°f to 77°f (20°c to 25°c) excursions permitted between 59 to 86°f (15 to 30°c) [see usp controlled room temperature] proper disposal - put your used needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic able to be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out upright and stable during use leak-resistant properly labeled to warn of hazardous waste inside the container - made of a heavy-duty plastic - able to be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out - upright and stable during use - leak-resistant - properly labeled to warn of hazardous waste inside the container - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. care and storage the apokyn pen can now be stored in its carrying case. never store or carry the apokyn pen with a pen needle attached. you must store and care for your pen the right way: - avoid exposure to dust, moisture, and cold or hot temperatures. - never wash the pen in water or use strong disinfectants. only a clean, damp cloth should be used for cleaning. - do not try to repair the pen if it is damaged or if you cannot solve a problem shown in the following "troubleshooting" section. - do not use pen for more than 1 year after the first use or after the expiration date on the carton. for more information, call your specialty pharmacy provider or 1-877-7apokyn (727-6596). troubleshooting

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

jurox pty limited - apomorphine hydrochloride - oral tablet - apomorphine hydrochloride alkaloid active 6.5 mg/tb - central nervous system - dog | bitch | castrate | puppy - emetic | induce vomiting

Australia - English - Department of Health (Therapeutic Goods Administration)

stada pharmaceuticals australia pty ltd - apomorphine hydrochloride hemihydrate, quantity: 50 mg - injection, solution - excipient ingredients: sodium metabisulfite; water for injections; sodium hydroxide; hydrochloric acid - movapo is indicated to reduce the number and severity of "off" phases in patients with parkinson's disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with movapo should be undertaken by a specialist unit in a hospital setting. conventional therapy should be continued during "on" phases.

Australia - English - Department of Health (Therapeutic Goods Administration)

stada pharmaceuticals australia pty ltd - apomorphine hydrochloride hemihydrate, quantity: 20 mg - injection, solution - excipient ingredients: sodium metabisulfite; water for injections; sodium hydroxide; hydrochloric acid - movapo is indicated to reduce the number and severity of "off" phases in patients with parkinson's disease severely disabled by motor fluctuations refractory to conventional therapy. initiation of therapy with movapo should be undertaken by a specialist unit in a hospital setting. conventional therapy should be continued during "on" phases.